Drug integrity. Shelf life. Stability. Purity. Risk reduction. Container closure integrity. All are daunting challenges that keep you awake at night. Meeting these challenges keeps you in business.
The importance of parenteral packaging selection
Bringing an innovative and novel drug product to market requires years of work and an enormous amount of capital and intellectual investment. Along the way, many important decisions are made that can impact critical timelines. Among these decisions is choosing a suitable container and closure for your drug product.
Drug integrity, stability, purity and efficacy can all be adversely affected if you select packaging components that are not chemically compatible with your drug product. Careful stopper selection is critical when packaging your product. West offers clean stopper formulations to meet the exacting requirements of drug products.
To minimize drug interaction with stopper components and help reduce the risk of drug contamination, a barrier film such as FluroTec® is designed to address this need.
When considering a stopper, cleanliness goes beyond the make-up of the rubber formula. Issues with bioburden, endotoxin and particulate are critical factors in stopper preparation, as well as the efficiency of sterile components, which is why West offers Westar® RU (Ready-to-Use) products.
Selecting the appropriate vial can help assure your drug product's shelf life by minimizing container/drug interaction. To address multiple market needs, West offers both glass vials and thermoplastic cyclic polyolefin vials and prefilled syringes, particularly attractive for oncology and extreme pH products. West also offers high-quality, ready-to-use prefilled syringe components with FluroTec barrier film.
To complete the package selection and mitigate the risks associated with failed container closure integrity, which can cause your drug product to lose efficacy and stability, it is beneficial to consider one of West’s Flip-Off® seals.
To help assure proper package selection and help avoid possible incompatibilities between drug product and container closure, West offers a product screening analysis. West also offers other package testing to meet regulatory requirements.